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Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial

Bath, Philip M; Scutt, Polly; Anderson, Craig S; Appleton, Jason P; Berge, Evind; Cala, Lesley; Dixon, Mark; England, Timothy M; Godolphin, Peter J; Havard, Diane; Haywood, Lee; Hepburn, Trish; Krishnan, Kailash; Mair, Grant; Montgomery, Alan A; Muir, Keith; Phillips, Stephen J; Pocock, Stuart; Potter, John; Price, Chris; Randall, Marc; Robinson, Thompson G; Roffe, Christine; Rothwell, Peter M; Sandset, Else C; Sanossian, Nerses; Saver, Jeffrey L; Shone, Angela; Niroshan Siriwardena, A; Wardlaw, Joanna M; Woodhouse, Lisa J; Venables, Graham; Sprigg, Nikola; Amarenco, Pierre; Muir, Keith; Amoils, Shannon; Jarvis, Malcolm; Rothwell, Peter M; Sandercock, Peter; Asplund, Kjell; Baigent, Colin; Ankolekar, Sandeep; Howard, Harriet; Lysons, Christopher; Walker, Gemma; Gregory, Hayley; Kirby, James; Smithson, Jennifer; Keeling, Joanne; Frowd, Nadia; Gray, Robert; Dooley, Richard; Clarke, Wim; Robinson, Patricia; Kang Law, Zhe; Hodgson, Sheila; Millington, Adam; Sakka, Eleni; Buchanan, David; P...

Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial Thumbnail


Authors

PHILIP BATH philip.bath@nottingham.ac.uk
Stroke Association Professor of Stroke Medicine

Polly Scutt

Craig S Anderson

Jason P Appleton

Evind Berge

Lesley Cala

Mark Dixon

Peter J Godolphin

Diane Havard

Lee Haywood

TRISH HEPBURN Trish.Hepburn@nottingham.ac.uk
Senior Medical Statistician

Kailash Krishnan

Grant Mair

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit

Keith Muir

Stephen J Phillips

Stuart Pocock

John Potter

Chris Price

Marc Randall

Thompson G Robinson

Christine Roffe

Peter M Rothwell

Else C Sandset

Nerses Sanossian

Jeffrey L Saver

Angela Shone

A Niroshan Siriwardena

Joanna M Wardlaw

Graham Venables

NIKOLA SPRIGG nikola.sprigg@nottingham.ac.uk
Professor of Stroke Medicine

Pierre Amarenco

Keith Muir

Shannon Amoils

Malcolm Jarvis

Peter M Rothwell

Peter Sandercock

Kjell Asplund

Colin Baigent

Sandeep Ankolekar

Harriet Howard

Christopher Lysons

Gemma Walker

Hayley Gregory

James Kirby

Jennifer Smithson

Joanne Keeling

Nadia Frowd

Robert Gray

Richard Dooley

Wim Clarke

Patricia Robinson

Zhe Kang Law

Sheila Hodgson

Adam Millington

Eleni Sakka

David Buchanan

Jeb Palmer

D Shaw

H Cobb

R Johnson

T Payne

R Spaight

A Spaight

M A Sajid

A Whileman

E Hall

H Cripps

J Toms

R Gascoyne

S Wright

M Cooper

A Palfreman

A Rajapakse

I Wynter

K Musarrat

A Mistri

C Patel

C Stephens

S Khan

S Patras

M Soliman

A Elmarimi

C Hewitt

E Watson

I Wahishi

J Hindle

L Perkin

M Wills

S Arif

S Leach

S Butler

D O'Kane

C Smith

J O'Callaghan

W Sunman

A Buck

B Jackson

C Richardson

G Wilkes

J Clarke

L Ryan

O Matias

D Mangion

A Hardwick

C Constantin

I Thomas

K Netherton

S Markova

A Hedstrom

B Rushton

C Hyde

J Scott

M Blair

M Maddula

R Donnelly

S Keane

S Johnson

H McKenzie

A Banerjee

D Hutchinson

H Goodhand

J Hill

K Mellows

M Cheeseman

V McTaggart

T Foster

L Prothero

P Saksena

A O'Kelly

H Wyllie

C Hacon

H Nutt

J North

K Goffin

J Potter

A Wiltshire

G Ravenhill

K Metcalf

L Ford

M Langley

W Davison

S Subramonian

F Magezi

I Obi

N Temple

N Butterworth-Cowin

P Oqwusu-Agyei

A F M Azim

A Nicolson

J Imam

J White

L Wood

R Fothergill

N Thompson

J Lazarus

H Werts

L Sztriha

C Ho

E McKenzie

E Owoyele

J Lim

J Aeron-Thomas

M Dockey

N Sylvester

P Rao

B M Bloom

E Erumere

G Norman

I Skene

L Cuenoud

L Howaniec

O Boulton

P Daboo

R Michael

S Al-Saadi

T Harrison

H Syed

L Argandona

S Amiani

R Perry

A Ashton

A Banaras

C Hogan

C Watchurst

E Elliott

N Francia

N Oji

R Erande

S Obarey

S Feerick

S Tshuma

E England

H Pocock

K Poole

S Manchanda

I Burn

S Dayal

K McNee

M Robinson

R Hancock

A South

C Holmes

A Steele

L B Guthrie

M Oborn

A Mohd Nor

B Hyams

C Eglinton

D Waugh

E Cann

N Wilmhurst

S Piesley

S Shave

D Dutta

M Obeid

D Ward

J Turfrey

J Glass

K Bowstead

L Hill

P Brown

S Beames

S O'Connell

V Hughes

R Whiting

J Gagg

M Hussain

M Harvey

D Karunatilake

B Pusuluri

A Witcher

C Pawley

J Allen

J Foot

J Rowe

C Lane

S Ragab

B Wadams

J Dube

B Jupp

A Ljubez

C Bagnall

G Hann

L Tucker

M Kelton

S Orr

F Harrington

A James

A Lydon

G Courtauld

K Bond

L Lucas

T Nisbett

J Kubie

A Bowring

G Jennings

K Thorpe

N Mason

S Keenan

L Gbadomishi

D Howcroft

H Newton

J Choulerton

J Avis

L Shaw

P Paterson

P Kaye

S Hierons

S Lucas

P Clatworthy

B Faulkner

L Rannigan

R Worner

B Bhaskaran

A Saulat

H Bearne

J Garfield-Smith

K Horan

P Fitzell

S Szabo

M Haley

D Simmons

D Cotterill

G Saunders

H Dymond

S Beech

K Rashed

A Tanate

C Buckley

D Wood

L Matthews

S Board

T Pitt-Kirby

N Rees

C Convery

P Jones

C Bryant

H Tench

M Dixon

R Loosley

S Coetzee

S Jones

T Sims

M Krishnan

C Davies

L Quinn

L Connor

M Wani

S Storton

S Treadwell

T Anjum

C Somashekar

A Chandler

C Triscott

L Bevan

M Sander

S Buckle

W Sayed

K Andrews

L Hughes

R Hughes

M Ward

A Pretty

A Rosser

B Davidson

G Price

I Gunson

J Lumley-Holmes

J Miller

M Larden

M Jhamat

P Horwood

R Boldy

C Jenkins

F Price

M Harrison

T Martin

N Ahmad

A Willberry

A Stevens

K Fotherby

A Barry

A Remegoso

F Alipio

H Maquire

J Hiden

K Finney

R Varquez

S Ispoglou

A Hayes

D Gull

R Evans

E Epstein

S Hurdowar

J Crossley

J Miles

K Hird

R Pilbery

C Patterson

H Ramadan

K Stewart

O Quinn

R Bellfield

S Macquire

W Gaba

A Nair

A Wilson

C Hawksworth

I Alam

J Greig

M Robinson

P Gomes

P Rana

Z Ahmed

P Anderston

A Neal

D Walstow

R Fong

S Brotheridge

A Bwalya

A Gillespie

C Midgley

C Hare

H Lyon

L Stephenson

M Broome

R Worton

S Jackson

R Rayessa

A Abdul-Hamid

C Naylor

E Clarkson

A Hassan

D Waugh

E Veraque

L Finch

L Makawa

M Carpenter

P Datta

A Needle

L Jackson

H J Brooke

J Ball

T Lowry

S Punnoose

R Walker

V Murray

A Ali

C Kamara

C Doyle

E Richards

J Howe

K Dakin

K Harkness

R Lindert

P Wanklyn

P Willcoxson

P Clark-Brown

R Mir



Abstract

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: High blood pressure is common in acute stroke and is a predictor of poor outcome; however, large trials of lowering blood pressure have given variable results, and the management of high blood pressure in ultra-acute stroke remains unclear. We investigated whether transdermal glyceryl trinitrate (GTN; also known as nitroglycerin), a nitric oxide donor, might improve outcome when administered very early after stroke onset. Methods: We did a multicentre, paramedic-delivered, ambulance-based, prospective, randomised, sham-controlled, blinded-endpoint, phase 3 trial in adults with presumed stroke within 4 h of onset, face-arm-speech-time score of 2 or 3, and systolic blood pressure 120 mm Hg or higher. Participants were randomly assigned (1:1) to receive transdermal GTN (5 mg once daily for 4 days; the GTN group) or a similar sham dressing (the sham group) in UK-based ambulances by paramedics, with treatment continued in hospital. Paramedics were unmasked to treatment, whereas participants were masked. The primary outcome was the 7-level modified Rankin Scale (mRS; a measure of functional outcome) at 90 days, assessed by central telephone follow-up with masking to treatment. Analysis was hierarchical, first in participants with a confirmed stroke or transient ischaemic attack (cohort 1), and then in all participants who were randomly assigned (intention to treat, cohort 2) according to the statistical analysis plan. This trial is registered with ISRCTN, number ISRCTN26986053. Findings: Between Oct 22, 2015, and May 23, 2018, 516 paramedics from eight UK ambulance services recruited 1149 participants (n=568 in the GTN group, n=581 in the sham group). The median time to randomisation was 71 min (IQR 45–116). 597 (52%) patients had ischaemic stroke, 145 (13%) had intracerebral haemorrhage, 109 (9%) had transient ischaemic attack, and 297 (26%) had a non-stroke mimic at the final diagnosis of the index event. In the GTN group, participants' systolic blood pressure was lowered by 5·8 mm Hg compared with the sham group (p

Citation

Bath, P. M., Scutt, P., Anderson, C. S., Appleton, J. P., Berge, E., Cala, L., …Mir, R. (2019). Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial. Lancet, 393(10175), 1009-1020. https://doi.org/10.1016/S0140-6736%2819%2930194-1

Journal Article Type Article
Acceptance Date Jan 14, 2019
Online Publication Date Feb 6, 2019
Publication Date Mar 9, 2019
Deposit Date Feb 8, 2019
Publicly Available Date Feb 11, 2019
Journal Lancet
Print ISSN 0140-6736
Electronic ISSN 1474-547X
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 393
Issue 10175
Pages 1009-1020
DOI https://doi.org/10.1016/S0140-6736%2819%2930194-1
Public URL https://nottingham-repository.worktribe.com/output/1529768
Publisher URL https://www.sciencedirect.com/science/article/pii/S0140673619301941#!

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